Duration of Music Interventions and Pain Tolerance (DOMINANT)

NCT06286137 | Completed

• 1 other identifier: NL82922.078.22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.

Conditions

Pain, Acute

Keywords

Music-induced analgesia

Outcome Measures

Primary Outcomes (1)

• Pain tolerance

  The primary objective of the study is the pain tolerance. This tolerance will be measured using electric stimuli directly after the 20 minutes of listening to music or sitting in silence. Each measurement will be performed three times. Results will be expressed in amperage.

  At the end of the intervention, after the 20 minutes of listening to music or sitting in silence. Measured at the same day as the experiment.

Secondary Outcomes (6)

• Heart rate variability (HRV)

  During the 20 minutes of listening to music or sitting in silence, and during the eletric stimuli directly after those 20 minutes. Measured at the same day as the experiment.

• Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire

  At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.

• Valence and arousal, Self-Assessment manikin (SAM) questionnaire

  At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.

• Music listening Questionnaire

  At baseline. Measured at the same day as the experiment.

• Pain intensity

  At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.

Study Arms (4)

Control group

ACTIVE COMPARATOR

The control group will be seated for 20 minutes without doing anything else, and not listen to music.

Other: Not listening to music

1 minute music group

EXPERIMENTAL

The 1 minute music group will be seated for 19 minutes without doing anything else, and listen to music for 1 minute.

Other: Listening to music for 1 minute

5 minutes music group

EXPERIMENTAL

The 5 minutes music group will be seated for 15 minutes without doing anything else, and listen to music for 5 minutes.

Other: Listening to music for 5 minutes

20 minutes music group

EXPERIMENTAL

The 20 minutes music group will listen to music for 20 minutes.

Other: Listening to music for 20 minutes

Interventions

Listening to music for 1 minute OTHER

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 19 minutes before the 1 minute music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).

1 minute music group

Listening to music for 5 minutes OTHER

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 15 minutes before the 5 minutes music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).

5 minutes music group

Listening to music for 20 minutes OTHER

Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 20 minutes through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels.

20 minutes music group

Not listening to music OTHER

Participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones), for a duration of 20 minutes.

Control group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 64 years of age
• Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
• Provision of written informed consent by subject

You may not qualify if:

• Significant hearing impairment
• Current complaints of tinnitus
• Current use of analgesic medication
• Presence of acute or chronic pain
• History of cardiac disease or arrhythmias
• Current treatment by a medical specialist or general practitioner
• Professional musician or singer (practicing in average \>1 hour each day)
• Pregnancy

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (8)

• Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.

  PMID: 29665028 BACKGROUND

• Fu VX, Oomens P, Klimek M, Verhofstad MHJ, Jeekel J. The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis. Ann Surg. 2020 Dec;272(6):961-972. doi: 10.1097/SLA.0000000000003506.

  PMID: 31356272 BACKGROUND

• Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666.

  PMID: 24552785 BACKGROUND

• Basinski K, Zdun-Ryzewska A, Greenberg DM, Majkowicz M. Preferred musical attribute dimensions underlie individual differences in music-induced analgesia. Sci Rep. 2021 Apr 21;11(1):8622. doi: 10.1038/s41598-021-87943-z.

  PMID: 33883585 BACKGROUND

• Valevicius D, Lepine Lopez A, Diushekeeva A, Lee AC, Roy M. Emotional responses to favorite and relaxing music predict music-induced hypoalgesia. Front Pain Res (Lausanne). 2023 Oct 25;4:1210572. doi: 10.3389/fpain.2023.1210572. eCollection 2023.

  PMID: 38028433 BACKGROUND

• Howlin C, Stapleton A, Rooney B. Tune out pain: Agency and active engagement predict decreases in pain intensity after music listening. PLoS One. 2022 Aug 3;17(8):e0271329. doi: 10.1371/journal.pone.0271329. eCollection 2022.

  PMID: 35921262 BACKGROUND

• Martin-Saavedra JS, Vergara-Mendez LD, Pradilla I, Velez-van-Meerbeke A, Talero-Gutierrez C. Standardizing music characteristics for the management of pain: A systematic review and meta-analysis of clinical trials. Complement Ther Med. 2018 Dec;41:81-89. doi: 10.1016/j.ctim.2018.07.008. Epub 2018 Jul 11.

  PMID: 30477868 BACKGROUND

• Lunde SJ, Vuust P, Garza-Villarreal EA, Vase L. Music-induced analgesia: how does music relieve pain? Pain. 2019 May;160(5):989-993. doi: 10.1097/j.pain.0000000000001452. No abstract available.

  PMID: 30507782 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Klimek, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chairman / Director Residency Training Program, Department of Anesthesiology

Model Details: The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 29, 2024
• Study Start: February 28, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)